Trina Linda A. Estoesta

**** ** ***** *****

San Marcos, California

92078

619-***-****

abm8ui@r.postjobfree.com

Objective:

To obtain a quality assurance position within a biotechnical or medical device organization

Qualifications:

Quality Engineering Technician

Quality Process Technician

Quality Assurance/ Quality Control Technician

Registered Pharmacy Technician

Education:

Apollo Root Cause Analysis for Practitioners Certification

San Diego State University, San Diego, California

Southwestern College, Chula Vista, California

Relevant Experience:

1) Guidant Corporation/Abbott Vascular, Product Performance Group, December 2005 to

Present:

Quality Assurance Technician/Quality Engineering Technician: Investigating product failure

via physical analysis of returned devices. Gathering and testing of new products from

manufacturing for comparison against returned products, including: testing to failure,

measurement and performance testing, visual analysis. Maintaining data of past complaints for

trending (examples: specific failures consistent with certain products can indicate a manufacturing

issue vs. Specific failures consistent with certain account can indicate a need for inservice

regarding product use). Maintaining quality records within the complaint handling database.

Performing root cause analysis and implementing corrective and preventative action (CAPA) for

complaints. Data entry of information into complaint database. Communication with accounts

regarding specific events and products. Manufacturing database (LHR) search for non-

conformance's(NCMRs), sub-assembly use, production line outputs. Opening field discrepancy

notification (FDN) reports to investigate possible product deficiencies. Interpreting relevant SOP

and DOPs. Communication with manufacturing engineering group regarding trends and potential

manufacturing practice or materials issues. Determining reportability of incoming complaints.

Providing customer service to accounts/clients.

2) Children’s Hospital and Health Center, Inpatient Pharmacy, July 1999 to March 2004:

Quality Control: Auditing of pharmacy and patient records for proper documentation of narcotic

usage and waste by nursing staff. Performing root cause analysis and implementing corrective

action for medication documentation and dispensing errors. Developed database to manage

narcotic accountability to track and trend nursing behaviors. Implemented tool to better track

narcotic usage and waste by staff.

Quality Assurance: Performing quality assurance audits of medication handling, dispensing, and

storage per hospital policy and procedure as determined by JCAHO standards. Reporting audit

findings medical director/safety officer. Training and qualification of new nursing hires in

automated pharmacy dispensing standards. Training of new pharmacy hires in pharmacy

practices and procedures per departmental standards, qualifying staff in departmental testing of

competencies. Proving samples of finished product to lab for analysis. Maintaining and updating

training qualifications and records.

Pharmacy Purchaser (assistant): Evaluating pharmacy inventory, billing practices, and usage

to enhance pharmacy revenue. Purchasing and validating incoming inventory. Recording of

controlled substances according to FDA regulations.

Registered Pharmacy Technician: Compounding and dispensing of TPN’s, chemotherapy, and

I.V. medications (syringe fill and compounded), cart fill of oral and unit dose meds within internal

pharmacy quality systems and pharmacy law. Knowledge of pharmaceutical calculations. First

response team to Code Blue/Code Trauma. Outpatient pharmacy technician duties.

Troubleshoot automix/micromix pumps/scales.

3) Health Solutions Pharmacy, May 1997 to December 1999:

Registered pharmacy technician : Card filling of cycle medications, filling of first and stat

doses. I.V. admixture. Insurance billing of medications. Medication returns processing.

4) Navcare Pharmacy, October 1991 to December 1997:

Registered pharmacy technician: In house pharmacy for high volume outpatient clinic.

Other Experience and Skills:

Pharmaceutical, chemical and materials purchasing

Inventory validation

Knowledge of medical terminology

Sterile/I.V. clean room procedures

Hazardous waste management training

Computer systems: Viper, Viewpoint, QS1, Interex, FSI, Meditech

Microsoft Word and Excel

REFERENCES:

Danielle Norris, Product Performance Engineer, 858-***-****

Maryann Rodgers, Quality Assurance Analyst, 760-***-****

Julie Higgenbottom Cronise, Pharm D, 731-***-****

Contact this candidate